Regulation (EC) No 2065/2003 (OJ L309, p1, 26/11/2003) of the European Parliament and of the Council of 10 November 2003 on smoke flavourings used or intended for use in or on foods
Regulation (EC) No 596/2009 (OJ L 188, p14, 18/07/2009) of the European Parliament and of the Council of 18 June 2009 adapting a number of instruments subject to the procedure referred to in Article 251 of the Treaty to Council Decision 1999/468/EC with regard to the regulatory procedure with scrutiny — Adaptation to the regulatory procedure with scrutiny — Part Four
Consolidated version of Regulation (EC) No 2065/2003 (as at 7th August 2009)
Commission Regulation (EC) No 627/2006 (OJ L109, p3, 22/04/2006 ) of 21 April 2006 implementing Regulation (EC) No 2065/2003 of the European Parliament and of the Council as regards quality criteria for validated analytical methods for sampling, identification and characterisation of primary smoke product
Authorised smoke flavouring primary products
Commission Implementing Regulation (EU) No 1321/2013 (OJ L333, p54, 12/12/2013) of of 10 December 2013 establishing the Union list of authorised smoke flavouring primary products for use as such in or on foods and/or for the production of derived smoke flavourings
The production of smoke flavourings starts with the condensation of smoke. The condensed smoke is normally separated by physical processes into a water-based primary smoke condensate, a water-insoluble high-density tar phase and water in soluble oily phase. The water-insoluble oily phase is a by-product and unsuitable for the production of smoke flavourings. The primary smoke condensates and fractions of the water-insoluble high-density tar phase, the ‘primary tar fractions’, are purified to remove components of smoke which are most harmful to human health. They may then be suitable for use as such in or on foods or for the production of derived smoke flavourings made by further appropriate physical processing such as extraction procedures, distillation, concentration by evaporation, absorption or membrane separation and the addition of food ingredients, other flavourings, food additives or solvents, without prejudice to more specific EU legislation.
Regulation (EC) No 2065/2003 applies to
1. smoke flavourings used or intended for use in or on foods;
2. source materials for the production of smoke flavourings;
3. the conditions under which smoke flavourings are prepared;
4. foods in or on which smoke flavourings are present
The Regulation provides for the scientific evaluation of primary smoke condensates and primary tar fractions, i.e. ‘primary products’, in terms of the safety of their use as such and/or for the production of derived smoke flavourings intended for use in or on foods.
EFSA assesses the safety of smoke flavourings which are used or intended for use in the EU. This task is carried out on the basis of applications submitted by companies for market authorisation. Guidance on the submission of applications as required under Regulation (EC) No 2065/2003 was published by EFSA in 2004. The document gives guidance on the administrative and technical data required, on the range of toxicological tests generally required for smoke flavouring primary products, and on the format for formal submissions to the competent authority of a Member State for further transmission to the European Food Safety Authority (EFSA). Applications must be submitted in accordance with Article 7 of Regulation (EC) No 2065/2003. A list of valid applications is available on the Europa website here.
In accordance with Directive 2000/13/EC, labelling of a food should not mislead consumers as to whether the product is smoked conventionally with fresh smoke or treated with smoke flavourings. Annex III to Directive 2000/13/EC specifies that the designation ‘smoke flavouring(s)’, or ‘smoke flavouring(s) produced from “food(s) or food category or source(s)”’ (e.g. smoke flavouring produced from beech), may only be used if the flavouring component contains flavourings as defined in Article 3(2)(f) of Regulation (EC) No 1334/2008 and imparts a smoky flavour to the food
Regulation (EC) No 1334/2008 defines ‘smoke flavouring’ in Article 3(2)(f) as meaning a product obtained by fractionation and purification of a condensed smoke yielding primary smoke condensates, primary tar fractions and/or derived smoke flavourings as defined in points (1), (2) and (4) of Article 3 of Regulation (EC) No 2065/2003.
Last reviewed: 16/9/2015